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Clinical Trials/EUCTR2011-000945-19-BE
EUCTR2011-000945-19-BE
Active, not recruiting
Phase 1

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection

Gilead Sciences Inc.0 sites10,470 target enrollmentApril 22, 2014
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ConditionsMedDRA version: 18.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]Genotype 1 Hepatitis C Virus InfectionMedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
MedDRA version: 18.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
Sponsor
Gilead Sciences Inc.
Enrollment
10470
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 22, 2014
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Willing and able to provide written informed consent;
  • •2\. Have previously participated in a Gilead\-sponsored hepatitis C study and received at least one Gilead OAV;
  • •3\. Have achieved SVR in a Gilead\-sponsored study, as defined in the original treatment protocol;
  • •4\. Be willing and able to comply with the visit schedule and protocol\-mandated procedures.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10000
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 470

Exclusion Criteria

  • •1\. Subject plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow\-up Registry.
  • •2\. History of clinically\-significant illness or any other major medical disorder that may interfere with subject follow\-up, assessments or compliance with the protocol.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
A long-term study to follow patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial.Genotype 1 Hepatitis C Virus InfectionMedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
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A long-term study to follow patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial.Genotype 1 Hepatitis C Virus InfectionMedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
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